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General Office of the State Council on Printing and Distributing National Organizational Drugs
Notification of centralized procurement and use of pilot programs
State Office issued [2019] No. 2
The people's governments of all provinces, autonomous regions and municipalities directly under the Central Government, ministries and commissions of the State Council, and their respective agencies:
The National Organizational Drug Centralized Procurement and Use Pilot Program (hereinafter referred to as the “Program”) has been approved by the State Council and is now issued to you. Please implement it carefully.
In accordance with the requirements of the "Program", each pilot city shall, in light of the actual formulation of the implementation plan and supporting policies, strengthen the organization of leadership, layer the responsibility, do a good job in propaganda and guidance, and prevent risks, and ensure the implementation of the pilot tasks. Relevant provinces should closely follow the implementation of the pilot, actively create conditions, give support to pilot cities, and strengthen guidance, supervision and assessment.
All relevant departments and units shall further decompose and refine the work involving their own units in accordance with the requirements of division of labor, promptly formulate specific measures, clarify the schedule, and promote implementation one by one. For the work involving multiple departments, the lead department should strengthen coordination and relevant departments should closely cooperate. It is necessary to enhance the overall concept, strengthen communication and cooperation, and have arrangements, supervision, and results. The National Organizing Committee for the Centralized Procurement and Use of Pharmaceuticals will work with relevant departments to conduct monitoring and analysis, regular notification, supervision and inspection, and summary assessment. It is necessary to carry out key supervisions on pilot areas with slow progress and ineffective results. Report to the State Council.
Office of the State Council
January 1, 2019
National organization of centralized drug procurement and use pilot program
According to the deployment of the Party Central Committee and the State Council, this plan was formulated to deepen the reform of the medical and health system, improve the drug price formation mechanism, and carry out pilot projects for centralized drug procurement and use by the state.
First, the overall requirements
(1) Target tasks. Choose Beijing, Tianjin, Shanghai, Chongqing and Shenyang, Dalian, Xiamen, Guangzhou, Shenzhen, Chengdu, Xi'an 11 cities, from the quality and efficacy of the consistency evaluation (including the approval of the new registration according to the chemical classification, referred to as consistency evaluation, The same generic drug corresponding to the generic drug selected by the generic drug, the national organization of centralized drug procurement and use pilot, to achieve a significant reduction in drug prices, reduce the burden of patients' drug costs; reduce corporate transaction costs, purify the circulation environment, improve the industry's ecology; Guide medical institutions to regulate drugs, support public hospital reforms; explore and improve drug centralized procurement mechanisms and market-oriented drug price formation mechanisms.
(2) The overall idea. In accordance with the general idea of state organization, alliance procurement, and platform operation, that is, the country formulates basic policies, scope, and requirements, organizes pilot areas to form alliances, and uses public medical institutions in the alliance areas as centralized procurement entities to explore cross-regional alliances to concentrate procurement. On the basis of summarizing the evaluation and pilot work, we will gradually expand the coverage of centralized procurement and guide the society to form long-term stable expectations.
(3) Basic principles. First, adhere to the people as the center, guarantee the demand for clinical drugs, effectively reduce the burden on patients, and ensure the quality and supply of drugs. Second, adhere to the law and compliance, strictly implement relevant policy provisions, ensure that the special procurement procedures are standardized, open and transparent, and accept the supervision of all parties. The third is to adhere to the combination of market mechanism and government role, respecting the market-oriented drug price formation mechanism, and giving better play to the government's platform, promoting docking, guaranteeing supply, and strengthening supervision. Fourth, adhere to a smooth transition, properly link up, and handle the relationship between the pilot work and existing procurement policies.
Second, the scope and form of centralized procurement
(1) Participating in the enterprise. The pharmaceutical production enterprises (the national distributor of imported drugs are regarded as production enterprises) within the scope of centralized procurement approved by the State Drug Administration and listed in the mainland China may participate.
(2) The scope of the drug. Pilot varieties were selected from generic drugs corresponding to generic drugs that passed the consistency evaluation.
(3) Shortlisted standards. Includes quality finalists and supply shortlisted standards. The quality finalist criteria mainly consider the clinical efficacy, adverse reactions, batch stability, etc. of the drug, and in principle, based on the consistency evaluation. The supply short-listing standard mainly considers the production capacity and supply stability of the enterprise, and can ensure that the enterprises that supply the procurement volume in the pilot area can be short-listed. The specific indicators for the short-listed standards are prepared by the Joint Procurement Office.
(4) Forms of centralized procurement. According to the number of production enterprises selected for each drug, the corresponding centralized procurement methods are adopted: if the number of production enterprises is 3 or more, the method of bidding and procurement is adopted; if the number of production enterprises is 2, the method of bargaining is adopted; There is only one, and the method of negotiating procurement is adopted.
Third, specific measures
(1) Purchasing with quantity, and changing the price by quantity. On the basis of the purchase amount submitted by the public medical institutions in the pilot area, the total purchase amount is estimated according to 60%-70% of the total annual drug consumption of all public medical institutions in the pilot area, and the quantity purchase is carried out, the quantity and price are linked, and the quantity is exchanged. Forming the centralized purchase price of the drug, the pilot city public medical institution or its representative shall sign a purchase and sales contract with the manufacturer according to the above-mentioned purchase price. For the remaining amount, all public medical institutions can still purchase other types of nets that are suitable for centralized procurement of provincial-level drugs.
(2) Enlisting and recruiting to ensure the use. Public procurement institutions in pilot areas should be used preferentially through centralized procurement of products determined by bidding, bargaining, negotiation, etc., to ensure that contracted quantities are completed within one year.
(3) Ensuring quality and ensuring supply. It is necessary to strictly implement the quality finalist standards and supply short-listing standards, effectively prevent the low-price bids that ignore quality, and strengthen the supervision of the quality of the entire chain of production, circulation and use of selected drugs. Under this premise, establish a survey, assessment, assessment and monitoring system for the quality and supply capacity of the finalists. The production enterprise independently selects the centralized procurement of the distribution enterprise with the distribution ability and good reputation, and establishes the emergency reserve, inventory and production stop report system of the production enterprise according to the purchase and sale contract. In the event of non-contractual supply, quality and supply, etc., compensation, disciplinary, withdrawal, alternative and emergency safeguard measures shall be taken to ensure the quality and supply of the drug.
(4) Guarantee the payment and reduce the transaction cost. As the first responsible person for the settlement of medicines, medical institutions shall settle accounts with enterprises in time according to the contract, and reduce the transaction costs of enterprises. Strictly check the medical institutions' failure to settle the payment of medicines on time. On the basis of the total budget, the medical insurance fund shall be paid in advance to the medical institution at a rate not less than 30% of the purchase amount. A conditional city can be directly settled by pilot medical insurance.
Fourth, policy convergence, three medical linkage
(1) Exploring the synergy between medical insurance payment standards and purchase prices in pilot cities. For centralized procurement of medicines, the centralized purchase price is used as the medical insurance payment standard within the scope of medical insurance. In principle, the original payment for the same generic name, the reference preparation, the generic drug that passed the consistency evaluation, and the medical insurance fund are paid the same. Standards are settled. The patient uses a drug whose price is higher than the payment standard. The part that exceeds the payment standard is paid by the patient. If the price of the drug used by the patient differs greatly from the centralized purchase price of the selected drug, the payment standard can be adjusted gradually, and the adjustment is made in 2-3 years. And formulate supporting policies and measures; patients use drugs whose price is lower than the payment standard, and pay according to the actual price. On the basis of guaranteeing quality and supply, guide medical institutions and patients to form reasonable medication habits.
(2) Promoting the reform of medical institutions through the transformation of mechanisms. Through the pilot, the drug price moisture is gradually squeezed out, the drug structure is improved, the drug occupation ratio of medical institutions is reduced, and space for public hospital reform is made. It is necessary to deepen the reform of medical insurance payment methods, establish an incentive and risk sharing mechanism between the medical insurance agencies and medical institutions, such as “residual retention and reasonable over-spending”, and promote the use of selected drugs at reasonable prices by medical institutions to reduce the operating costs of public medical institutions. If the medical service revenues and expenditures of public medical institutions form a balance, they can be used according to the “two permissions” (allowing medical and health institutions to break through the current level of wage adjustment and control of medical institutions, allowing medical service income to be deducted from costs and withdrawing funds according to regulations, mainly used for personnel rewards. The requirements are co-ordinated for personnel compensation expenses.
(3) Reinforce the responsibility of the medical institution to ensure the dosage. Encourage the use of selected drugs in centralized procurement, and incorporate the use of selected drugs into the performance appraisal of medical institutions and medical personnel. All relevant departments and medical institutions shall not influence the drug selection based on the cost control, the proportion of drugs, and the quantity requirements of medical institutions. Reasonable use and supply guarantee. For medical institutions that do not purchase and use drugs according to regulations, they shall be punished in the total medical insurance index, the awarding funds for public hospital reform, the evaluation of medical institutions, the qualification of medical insurance, and the assessment of the target responsibility of medical institutions. For medical personnel who do not use the drugs according to the regulations, they shall be dealt with seriously according to the corresponding provisions of the Prescription Management Measures and the Hospital Prescription Review Management Regulations (Trial). It is necessary to further improve the clinical application guidelines for drugs, strengthen the monitoring of drug use in medical institutions, strictly review prescriptions and prescriptions, strengthen the training of physicians and pharmacists, organize comprehensive clinical evaluation of drugs, promote scientific and rational drug use, and ensure the safety of patients.
(4) Clarify departmental responsibilities and do a good job of policy linkage. In order to ensure that the national organization of centralized drug procurement and use pilots to achieve the purpose of reducing drug prices and promoting reform, the medical insurance, medical and pharmaceutical authorities must perform their respective duties and coordinate linkages. The National Medical Insurance Bureau undertakes the responsibility of formulating the pilot program, relevant policies and supervision and implementation, and guides the local medical insurance departments to do the work of medical insurance payment, settlement and total budget management; the health departments at all levels are responsible for guiding the implementation of the selected drugs in medical institutions. Supervise, monitor and forecast the shortage of medical drugs, and guide the reform of public hospitals; the State Food and Drug Administration is responsible for identifying the varieties and drug manufacturers that have passed the consistency evaluation, and the provincial drug regulatory departments should strengthen the supervision and inspection of the quality of the selected drugs. To urge production enterprises to implement production stop report measures.
V. Organizational form
(1) Establish a pilot working group and office. The State Council General Office, the State Medical Insurance Bureau, the National Health and Health Commission, and the State Food and Drug Administration form a national working group for the centralized procurement and use of drugs (hereinafter referred to as the pilot working group) to lead the pilot work, study major issues, and deploy key tasks. The pilot working group office is located in the National Medical Insurance Bureau. It is selected by the National Medical Insurance Bureau, the National Health and Health Commission, the State Food and Drug Administration, and the Joint Procurement Office. It is responsible for organizing the pilot and coordinating the work between the departments and between the departments and the localities. Strengthen publicity and guidance and policy interpretation.
(2) Establishing a joint procurement office. Under the leadership of the pilot working group and its office, a joint procurement office was established to carry out centralized procurement on behalf of the alliance area. The Joint Procurement Office is composed of one representative from each pilot city. The director candidates are determined by the pilot areas. The representatives of the pilot areas are the deputy directors. They are responsible for implementing centralized procurement on behalf of the public medical institutions in the pilot areas, and organizing and supervising the implementation of centralized procurement. The Shanghai Pharmaceutical Centralized Bidding and Purchasing Management Office will undertake the daily work of the Joint Procurement Office and be responsible for the specific implementation. The Joint Procurement Office has a supervision team, an expert group, and a centralized procurement team.
1. Supervisory group. Responsible for supervising the centralized procurement of drugs, timely accepting and handling related reports and complaints.
2. Expert group. Organize experts in several fields (including experts recommended by national academic organizations, experts from the Hong Kong Hospital Authority and relevant experts recommended in the pilot areas) to set up an expert group to provide technical advice on relevant policies, clinical use, procurement operations.
3. Centralized procurement team. Responsible for centralized procurement of specific implementation work, the Joint Procurement Office will train the members of the centralized procurement team, and sign a letter of integrity, confidentiality and interest avoidance.
Work arrangements
The Joint Procurement Office will summarize the drug usage information of the public medical institutions in the pilot areas, further improve the implementation plan based on the pilot program and the actual situation of the pilot, draft and publish the centralized procurement announcement, carry out the specific work of centralized drug procurement, announce the procurement results, and urge the implementation of the pilot areas. Purchasing results and strengthening supervision and inspection. The pilot area completed the network at the provincial procurement platform according to the centralized procurement price. The centralized procurement entity signed the purchase and sales contract with the enterprise at the centralized purchase price and implemented the procurement. The centralized procurement result was started in early 2019 with a period of one year. The pilot working group office provides guidance and supervision on the whole process of centralized procurement and use. In case of major problems, the Joint Procurement Office and the pilot area shall report to the Office of the Pilot Working Group in a timely manner.
